INSTITUTIONAL CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM
Release Date: February 17, 2000 (see replacement PAR-03-083)
PA NUMBER: PAR-00-063
National Cancer Institute
Letter of Intent Receipt Date: May 1 every year
Application Receipt Date: June 1 every year
This Program Announcement (PA) replaces PAR-99-077, Clinical Oncology
Research Career Development Program, which was published in the NIH Guide on
March 23, 1999.
PURPOSE
The purpose of the National Cancer Institute (NCI) Institutional Clinical
Oncology Career Development Program is to increase the number of medical
doctors (M.D.’s, D.O.’s) and doctorally degreed Oncology Registered Nurses
who are motivated and properly trained to: (1) communicate and collaborate
with basic/behavioral research scientists in order to expedite the
translation of basic/ behavioral research information into patient-oriented
cancer research; (2) perform independent clinical oncology research that
develops and tests rational scientific hypotheses based on fundamental and
clinical research findings with the potential for improving the medical care
of cancer patients; and (3) design and test innovative clinical protocols and
manage all phases (i.e., pilot/Phase I, Phase II, and Phase III) of clinical
trials research. To achieve this purpose, awards are made to institutions
for up to five years for the development and implementation of training
programs providing clinicians with all of the necessary information and
training that will enable them to design, implement and manage all phases of
cancer clinical trials research. The distinguishing features of this career
development Program are that a Program Leader in the institution together
with an Advisory Committee selects the candidates and oversees the course of
their training, and that candidates are likely to have more than one mentor
as they are exposed to the basic sciences and to the many disciplines
critical to the clinical sciences.
For the purposes of this award patient-oriented research is defined as
research conducted with human subjects (or on material of human origin such
as tissues, specimens and cognitive phenomena) for which an investigator
directly interacts with human subjects. These areas of research include: 1)
mechanisms of human disease; 2) therapeutic interventions; 3) clinical
trials; and 4) the development of new technologies.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a
PHS-led national activity for setting priority areas. This PA,
“Institutional Clinical Oncology Research Career Development Program,” is
related to the priority areas of cancer and human resource development.
Potential applicants may obtain a copy of "Healthy People 2000" at
(http://odphp.osophs.dhhs.gov/pubs/hp2000).
ELIGIBILITY REQUIREMENTS
Institution: Applications may be submitted by domestic, for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Applicant organizations should have
well-established research programs with adequate peer-reviewed grant support
in cancer research and appropriate, highly qualified faculty in the clinical,
behavioral and basic sciences as needed to meet the objectives of the
proposed career development program.
Program Leader/ Principal Investigator: The Program Leader/ Principal
Investigator must be an established investigator in patient-oriented research
and able to provide both administrative and scientific leadership to the
Program. Minorities, women and individuals with disabilities are encouraged
to apply as program leaders/principal investigators.
Clinician Candidates: All candidates must currently be physicians holding the
M.D. or D.O. degrees, or be doctorally prepared oncology registered nurses;
and must have completed their clinical training (i.e., completed residency
and are board eligible). Candidates must be able to spend a minimum of 75
percent effort conducting research and research career development including
taking courses during the period of the award.
All clinician candidates must be citizens or non-citizen nationals of the
United States, or must have been lawfully admitted to the United States for
permanent residence (i.e., in possession of a currently valid Alien
Registration Receipt Card I- 551, or other legal verification of such
status). Non-citizen nationals are generally persons born in outlying
possessions of the United States (i.e., American Samoa and Swains Island).
Individuals on temporary visas are not eligible.
Clinician candidates who were former principal investigators on NIH Small
Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) remain
ELIGIBLE. However, former principal investigators on NIH research project
grants (i.e., R01s), FIRST Awards (i.e., R29s), sub-projects on Program
Project Grants (i.e., P01s) or on center grants (i.e., P50s) and the
equivalent are NOT ELIGIBLE. Candidates who have been supported on NIH or
non-NIH career development awards dedicated to training patient-oriented
researchers are NOT ELIGIBLE. However, while in general candidates who have
been supported on other types of career awards are not eligible, if their
training did not focus on clinical research and they can benefit from at
least two years of additional training on a K12 Program, they are ELIGIBLE.
MECHANISM OF SUPPORT
Support of this Program will be through the National Institutes of Health
(NIH) Mentored Clinical Scientist Development Program award or K12 mechanism.
Planning, direction, and, execution of the program will be the responsibility
of the Program Leader/Principal Investigator and the Advisory Committee on
behalf of the applicant institution. The project period is five years.
Awards are renewable.
Awards will be administered under NIH grants policy as stated in the National
Institutes of Health Grants Policy Statement, NIH Publication No. 99-8,
October 1998. However, the K12 award, as administered by the National Cancer
Institute, is not subject to “Just-in-time” application procedures or to the
Streamlined Noncompeting Application Process (SNAP). The K12 remains under
“Expanded Authorities” except that carryover of funds from one fiscal year to
the next requires approval by the NCI.
RESEARCH OBJECTIVES
A. Background: In 1991 the National Cancer Institute (NCI) recognized the
need for establishing formal training programs that would prepare the next
generation of clinical scientists to participate more effectively in
translational research. The NCI embarked on a pilot program initiative that
would prepare clinical oncologists to be effective scientific partners with
basic/behavioral scientists in the movement of discoveries in the laboratory
into patient research settings or the reverse process of taking observations
in the clinic back into a laboratory research setting. These well-trained
clinical oncology researchers would be expected to communicate, interact and
collaborate with basic/behavioral scientists in the design and implementation
of clinical trials that were hypothesis driven and based on an understanding
of biological mechanisms. This pilot program initiative was implemented
through two successive RFAs in 1992 and 1997 and was founded on the following
principles: (1) unlike career awards to individuals, these would be awards to
institutions and the institution would appoint individuals to a formal
training Program; (2) rather than having a single mentor, the individuals on
the program would likely have more than one mentor as they are exposed to the
basic sciences and to the many disciplines critical to the clinical sciences;
(3) the Program would provide individuals with all of the information and
training needed to design, implement and manage all phases of clinical trials
research.
This initial pilot Program was highly successful and had generated
considerable interest in the cancer research community. It became clear that
advertising the Program every five years as an RFA would not provide
sufficient opportunity for this community to submit applications. The
conclusion was that NCI objectives would be better served by making this
grant mechanism open to investigator-initiated applications on a regular
basis using a Program Announcement (PA). As a result, the NCI decided to
establish the Clinical Oncology Research Career Development Program(K12) as
an ongoing PA with a once-a-year submission date. Additionally, due to the
critical role of oncology nursing in clinical cancer the PA extends
eligibility to include doctorally prepared Oncology Registered Nurses. The
expectation of the NCI is that this kind of training program will greatly
enhance and promote the multidisciplinary research approaches and team
concepts needed for conducting clinical cancer research and for delivering
optimum cancer patient care.
The levels of salary and research support offered in the previous RFA’s and
PAs have been increased in this PA to levels consistent with the support
offered clinicians in the NCI in its individual career awards.
B. Program: The award provides support to institutions for five consecutive
12-month periods. Appointments of clinical candidates to the program are
provided in 12-month increments. These appointments may be as long as seven
years. The program provides research career development opportunities in more
than one clinical oncology research discipline (e.g., medical oncology,
surgical oncology, radiation oncology, oncology nursing, etc.). Both the
didactic and the research phases of the award are expected to develop the
necessary knowledge and research skills in scientific areas relevant to the
career goals of the candidate in clinical research. Candidates lacking
skills in data management, statistics, epidemiology, study design, clinical
trial design, hypothesis development, drug development, etc. will be provided
the opportunity to participate in courses designed to overcome these
deficiencies.
C. Environment: The institution must have a well-established research and
clinical career development program, and faculty qualified in clinical
research with an emphasis on patient-oriented research to serve as faculty
for the program. The research environment should be one in which there are
active basic/behavioral/clinical research collaborations that exemplify a
dynamic two-way exchange of information and ideas between laboratory and
clinical scientists. The research environment should also promote rapid
translation of basic/behavioral/oncology research into clinical testing as
well as stimulate new ideas and laboratory experiments, based on clinical
observations and testing results. Finally, the institution must demonstrate
a commitment to the development of trainees as productive, independent
investigators.
D. Allowable costs:
1. Direct cost cap: By NCI policy total direct costs cannot exceed $700,000
per annum. However, because NIH policy requires that any application
exceeding $500,000 per year in direct costs receive permission from the
funding institute before it can be accepted for review, any applicant
planning to request more than $500,000 must submit the K12 application with a
cover letter identifying the NCI Official by name who granted permission.
2. Salary: Clinician research candidates may be provided salary support of
up to $75,000 each year, plus fringe benefits commensurate with the applicant
institution's salary structure for persons of equivalent qualifications,
experience, and rank. The institution may supplement the NCI contribution;
however, supplementation may not be from Federal funds unless specifically
authorized by the Federal program from which such funds are derived. In no
case, may PHS funds be used for salary supplementation. Institutional
supplementation of salary may not require extra duties or responsibilities
that would interfere with the purpose of this award. The total salary
requested must be based on a full-time, 12 month staff appointment.
Salary support for the Program Leader/Principal Investigator and
participating faculty is not allowed.
3. Research and Development Support: Up to $30,000 per candidate can be
provided for the following types of expenses: (a) research expenses, such as
supplies, equipment and technical personnel; (b) tuition, fees and books
related to career development; (c) travel to research meetings or training;
and (d) statistical services including personnel and computer time. These
costs must be specifically documented for each individual candidate and must
be specifically and directly related to the candidate’s research activities.
They cannot be pooled and used for advertising, recruiting or other programs
unrelated or indirectly related to the research activities of individual
candidates or trainees.
4. Ancillary Personnel Support: Salaries for mentors, secretaries,
administrative assistants and other ancillary personnel are not allowed.
5. Facilities and Administrative Costs: These costs, which were formerly
called indirect costs, will be reimbursed at 8 percent of modified total
direct costs.
6. The K12 grant, as administered by the NCI, is not subject to the
Streamlined Noncompeting Application Process (SNAP). In general this means
that all reporting of budgetary information and program progress are provided
in greater detail in an annual progress report. While the K12 is subject to
Expanded Authorities, the one exception to this is that carryover of funds
from one fiscal year to the next must be approved by the NCI Grants
Administration staff (see INQUIRIES).
7. Other Income: Fees resulting from clinical practice, professional
consultation, or other comparable activities required by the research and
research-related activities of this award may not be retained by the career
award recipient. Such fees must be assigned to the grantee institution for
disposition by any of the following methods:
The funds may be expended by the grantee institution in accordance with the
NIH policy on supplementation of career award salaries and to provide fringe
benefits in proportion to such supplementation. Such salary supplementation
and fringe benefit payments must be within the established policies of the
grantee institution.
The funds may be used for health-related research purposes.
The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks
should be made payable to the Department of Health and Human Services, NIH
and forwarded to the Director, Division of Financial Management, NIH,
Bethesda, Maryland 20892. Checks must identify the relevant award account
and reason for the payment.
Awardees may retain royalties and fees for activities such as scholarly
writing, service on advisory groups, or honoraria from other institutions for
lectures or seminars, provided these activities remain incidental and
provided that the retention of such pay is consistent with the policies and
practices of the grantee institution.
Funds budgeted in an NCI-supported research or research training grant for
the salaries or fringe benefits of individuals, but freed as a result of a
K12 award, may not be rebudgeted.
E. Special Leave: Leave to another institution of a trainee, including a
foreign laboratory, may be permitted if directly related to the purpose of
the award. Only local, institutional approval is required if such leave does
not exceed 3 months. For longer periods, prior written approval of NCI staff
is required. To obtain prior approval, the trainee must submit a letter to
NCI Program staff describing the plan, countersigned by his or her department
head and the appropriate institutional official. A copy of a letter or other
evidence from the institution where the leave is to be taken must be
submitted to assure that satisfactory arrangements have been made. Support
from the award will continue during such leave.
Leave without award support may not exceed 12 months. Such leave requires
the prior written approval of the NCI and will be granted only in unusual
situations. Support from other sources is permissible during the period of
leave. Parental leave will be granted consistent with the policies of the
NCI and the grantee institution.
F. Termination: When a grantee institution plans to terminate an award, the
NCI must be notified in writing at the earliest possible time so that
appropriate instructions can be given for termination.
G. Change of Institution: The Clinical Oncology Career Development Program
(K12) cannot be transferred from one institution to another.
H. Change of Program Director: If the program director moves to another
institution or resigns from the position, support of the award may be
continued with NCI prior approval provided:
o The current program director or the awardee institution has submitted a
written request for change of program director, countersigned by the
appropriate institutional business official, to the NCI Program Director
describing the reasons for the change. The biosketch of the proposed new
program director, including a complete listing of active research grant
support, is provided. The information in the request establishes that the
specific aims of the original peer reviewed research program to be conducted
under the direction of the new program director will remain unchanged, and
that the new program director has the appropriate research and administrative
expertise to lead the program;
o The request is submitted far enough in advance of the requested effective
date to allow the necessary time for review.
I. Changes of Program: Awards are made to a specific institution for a
specific program under the guidance of a particular program director.
Changes in any of these parameters requires prior approval by NCI Program
staff.
A scientific rationale must be provided for any proposed changes in the aims
of the original peer reviewed program. The new program will be evaluated by
NCI staff to ensure that the program remains within the scope of the original
peer reviewed research program. If the new program does not satisfy this
requirement, the award could be terminated.
J. Progress Reports: An Annual Progress Report for the grant is required.
This report should provide information about changes in the Program, a
summary report of the evaluation of the Advisory Committee, and a description
of the research and career progress of each candidate. These Annual Reports
will be closely monitored by NCI staff to ensure that the grant is achieving
the goals of this Institutional Clinical Oncology Research Career Development
Program.
Progress reports are submitted using the Form PHS 2590, which can be obtained
at the following website address:
https://grants.nih.gov/grants/funding/2590/2590.htm. Forms are also available
at most institutional offices of sponsored research.
Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the
application for continuation to contain the following information:
- Appropriate Face Page A as instructed in the Form PHS 2590.
- A budget page B that provides the salary and fringe benefits for each
candidate or trainee by name or by position if no individual is filling the
position at the time of the application. Provide all other budgetary
information (e.g., supplies, travel, technical help)by trainee name or by the
position broken out specifically for each candidate and or trainee up to the
$30,000 limit.
- A brief description of the Objectives and Goals of the Program
- A brief summary listing by name delineating which faculty, mentors and
Advisory Committee members have left the Program and which new individuals
have been added or are taking their places. Include for each person their
degree and department affiliation (or equivalent).
- Biographical sketches of
i. New faculty
ii. New mentors
iii. New Advisory Committee Members
iv. New Trainees
- Progress of Individual Trainees: A brief paragraph for each candidate or
trainee describing the research and didactic training experiences completed
and ongoing, as well as the specific future plans for satisfying the Core
Requirements of the Program.
- List of publications for each trainee resulting from their work in the
Program.
- Summary information of the Program: A sample table can be obtained from the
NCI program staff (see INQUIRIES)
- A Report from the Advisory Committee (AC) that is separately attached
summarizing the actions of the AC during the last year, evaluating the
performance of the Program in meeting its objectives and the intent of the
NCI, evaluating the effectiveness of recruitment strategies (provide a
separate evaluation for minority recruitment), and providing recommendations
for improving the Program (e.g., new mentors, changes in Core Requirements,
changes in recruitment strategies etc.)
A final progress report, invention statement, and Financial Status Report are
required upon either termination of an award or relinquishment of an award in
a change of institution situation.
K. Evaluation: In carrying out its stewardship of human resource related
programs, the NCI may request information essential to an assessment of the
effectiveness of this program. Accordingly, recipients are hereby notified,
that they may be contacted after the completion of this award for periodic
updates on various aspects of their employment history, publications, support
from research grants or contracts, honors and awards, professional
activities, and other information helpful in evaluating the impact of the
program.
SPECIAL REQUIREMENTS
1. The Program Director must use an Advisory Committee to provide an
oversight function and annual evaluation of the clinical research development
program as a whole. Clinical, basic and behavioral science departments, and
oncology nursing departments participating in this program should be
represented on the committee by clinical investigators from the various
oncology disciplines such as medical oncology, surgical oncology, radiation
oncology, oncology nursing and other oncology specialties as well as by basic
and behavioral research investigators. The committee's responsibilities
might include: selecting physician and oncology nurse candidates, assigning
preceptors, approving each candidate's clinical research development plan,
evaluating each candidate's progress, and monitoring the overall
effectiveness of the program. A detailed description should be provided of
the committee's composition, function, and frequency of meetings. A summary
report of the actions of the committee meetings must be provided in the
annual progress report of the grant. Plans for an annual evaluation of the
program by the Advisory Committee should be described.
2. These Institutional Clinical Oncology Career Development Programs must
involve staff and clinical candidates representing at least two clinical
oncology disciplines such as medical, surgical, radiation, pediatric,
gynecologic oncology and oncology nursing.
3. The program must provide clinician candidates with the patient-oriented
research skills that deal directly with aspects of cancer detection,
diagnosis, prognosis, or treatment of cancer patients; and should provide the
skills necessary for translating basic/ behavioral cancer research results
into clinical experiments, procedures, and trials directly involving cancer
patients in a clinical environment. It will not be sufficient within the
scope of this initiative to use human cells and other clinical materials in
an isolated basic laboratory setting as the total research development
program. Basic laboratory/behavioral research experience is essential, but
it must be properly integrated with patient-oriented clinical research,
thereby affording the candidate actual experience in the application of their
own basic research to clinical research.
4. The program should have the flexibility to accommodate clinical
candidates with different levels of research experience and competence (also
see 6. below on Core Requirements).
5. Appointments of clinical candidates to the program should be for a
minimum of two years. As long as a K12 has been renewed, individual
candidates can be supported for up to seven years.
6. The Program should include Core Requirements that each candidate is
expected to complete before meeting the Program’s training objectives. These
requirements should include the following:
a. A didactic core component (e.g. formal courses in clinical trial design,
biostatistics, informed consent, Institutional Review Boards; lecture
series, seminars, and journal clubs) based on the experience and needs of
each candidate. In those institutions with a Clinical Research Curriculum
(K30) Award, the didactic component should link with and incorporate the new
didactic programs developed though the K30 award.
b. A clinical research core component that provides “hands-on” experience
(e.g., protocol development; preparation of IRB applications; clinical trials
management including patient accrual, analysis of outcomes) in all aspects of
clinical trials.
c. A basic research core component that adequately prepares the trainee for
communication, coordination and collaboration of clinical research activities
with basic scientists; ideally this would be linked to the core clinical
research component.
The expectation of the NCI is that candidates entering the Program with
different backgrounds initially will satisfy many of the Core Requirements
and that they will be provided with the additional didactic and research
experiences over different periods of time in order to fully meet the
objectives of the Program.
7. A minimum of 75 percent effort must be devoted to the basic/clinical
research program. The remaining 25 percent can be divided among other
clinical and teaching activities only if they are consistent with the program
goals, i.e. the candidate's development into an independent clinical oncology
researcher.
8. The institution must have a well-established research and clinical career
development program, and faculty qualified in clinical research with an
emphasis on patient-oriented research to serve as faculty for the program.
The research environment should be one in which there are active
basic/behavioral/clinical research collaborations that exemplify a dynamic
two-way exchange of information and ideas between laboratory and clinical
scientists. The research environment should also promote rapid translation
of basic/behavioral/oncology research into clinical testing as well as
stimulate new ideas and laboratory experiments, based on clinical
observations and testing results.
9. The institution must demonstrate a commitment to the development of
trainees as productive, independent investigators.
10. Where there already exists an active institutional (T32) National
Research Service Award (NRSA) supporting a surgical or other clinical
oncology research training program, the applicant must address the
relationship between the existing T32 and proposed K12 programs. If there is
significant overlap in the programs, the T32 award can be merged into the K12
program or modified to remove areas of substantial overlap.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research" which have been published in the Federal register of March 28, 1994
(FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994. It is also available electronically at URL address:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html.
Investigators may also a obtain copy of the policy from the program staff or
contact person listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
NIH, unless there are clear and compelling scientific and ethical reasons not
to include them. This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH GUIDE FOR
GRANTS AND CONTRACTS, March 6, 1998 and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.
LETTER OF INTENT
Prospective applicants are asked to submit by May 1 of every year a Letter of
Intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities
of other key personnel and participating institutions, and the number and
title of the PA in response to which the application may be submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NCI staff to estimate the potential review workload and avoid
conflict of interest in the review.
The Letter of Intent is to be sent to the program staff listed under
INQUIRIES.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application Form PHS 398 (rev.
4/98) using the modified instructions provided below and will be accepted
once every year on June 1. Application forms can be obtained directly at the
following website address:
https://grants.nih.gov/grants/funding/phs398/phs398.html. Forms are also
available at most institutional offices of sponsored research and from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, Phone: (301) 710-0267, FAX: (301) 480-0525, E-mail: GrantsInfo@nih.gov.
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view Internet sites. Reviewers are cautioned that their anonymity may be
compromised when they directly access an Internet site (see
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).
The instructions in the Form PHS 398 do not fully apply to the special needs
of this grant application. Detailed budgets must be provided in the
application. Therefore, please follow the modified instructions below in
preparing an application for an NCI Institution Clinical Oncology Career
Development Program(K12). These instructions have been adapted to
accommodate the Form PHS 398 and the special needs of the K12 grant:
1. Face Page: Use page AA of the PHS Form 398. On Line 1, include the
title that best represents the nature of the training program. On Line 2,
provide the number of this Program Announcement beginning with PAR..., and
the title “Institutional Clinical Oncology Research Career Development
Program” of the Program Announcement. The program Leader will be the
principal investigator (PI) of the grant application.
2. The Description/ Performance site(s)/ Key personnel (page BB of Form PHS
398): Complete as directed in the Form PHS 398, page IV-2. The information
provided should include the P.I., Advisory Committee members, mentors and
other faculty participating in the program.
3. Table of Contents to be organized as follows:
Content
Page Number
a. Face Page
b. Description/Key Personnel
c. Table of Contents
d. Statement of Commitment
e. Detailed Budget Page for First Year
f. Budget for Entire Proposed Period of Support
g. Biographical Sketches (not to exceed two pages per individual)
- Program Leader
- Advisory Committee Members
- Mentors
- Other Faculty
- Trainees (if available)
h. Other Support of the Principal Investigator and the Mentors that
is specifically
relevant to the purpose and objectives of this Program
i. Career Development/Training Plan (not to exceed 25 pages)
i. Introduction to Revised Application (when applicable, not
to exceed 3 pages)
ii. Purpose and Objectives
iii. Description of Core Requirements
iv. Research Base/Resources and Facilities/ Mentors
v. Program Management
- Program Leader
- Recruitment Strategies
- Advisory Committee
- Individual Training Plans
j. Human Subjects
k. Vertebrate Animals
l. Checklist
m. Appendices
4. Statement of Commitment: This statement should guarantee that all
candidates participating in this Program will commit 75% of a full-time
professional effort to research and research career development.
5. Detailed Budget for the First Year: Use Page 4 (or DD) of the Form PHS
398 and provide detailed budget information with regard to Salary and Fringe
benefits, supplies, travel etc. specified for each trainee by name or by
position, if there is no one available to fill the position
Note there is an upper limit of salary of $75,000 plus fringe benefits and an
upper limit for other costs of $30,000 per trainee.
6. Budget for the Entire Proposed Period of Support: Follow instructions as
provided in the Form PHS 398.
7. Biographical Sketches: Provide biographical sketches using page FF
provided in the Form PHS 398 kit. Divide into five sections as follows: (1)
Program Leader/Principal Investigator; (2) Advisory Committee Members; (3)
Mentors; (4) Other Faculty; (5) Trainees (when available).
8. Career Development/Training Plan:
a. Purpose and Objectives:
Briefly describe the background, purpose and objectives of this
career development Program. This description should identify two or more
clinical oncology disciplines represented in the Program and a discussion of
the strategies to be used to ensure that the representation in each
discipline in the mentor population and the trainee population will satisfy
the intent of this NCI requirement. The description should clearly show how
the purpose and objectives of the Program will meet the broader objectives
and intent of the NCI to prepare candidates who can design and implement all
phases of clinical trials and who can effectively participate in
translational research projects involving human clinicians and basic
scientists.
b. Description of Core Requirements:
Describe the core didactic, core clinical research and core basic
research experiences that each clinician candidate or trainee must complete
to satisfy the overall Core Requirements of the Program. Describe how
individualized trainee career development plans will be developed that take
into account past experiences and competencies before providing new
experiences and skills by the Program. Describe any certification, degree or
other form of recognition, if any, that trainees will receive after
completing the Core Requirements.
c. Research Base/Resources and Facilities/Mentors (consult NCI Program Staff
in the INQUIRIES section below for a suggest format for providing this
information)
Research Base: Describe the existing funded laboratory and
patient-oriented research activities and the interactive nature of the
research environment that will meet and sustain needs of this Program
Resources and Facilities: Describe the research infrastructure,
patient populations, facilities etc. that are available and accessible to
this Program.
Mentors: Describe the pertinent research experience and track
record in training cancer clinician scientists of each mentor participating
in the Program.
d. Program Management:
Program Leader: Describe the qualifications and role of the
Program Leader to provide scientific and administrative leadership and
coordination of the Program.
Recruitment Strategies: Describe the selection criteria for
candidates recruited to this Program. Describe the various strategies that
will be used to ensure that the different clinical oncology disciplines
represented by the Program are included and to ensure an adequate candidate
pool. Address the nature of any other competing institutional Programs that
might limit the number of candidates and describe the strategies for
addressing this competition. Describe plans for recruitment of under-
represented (e.g., African Americans, Hispanic Americans, Native Pacific
Islanders, Native Americans and Alaskan Natives) and how these strategies
will be implemented.
Advisory Committee (AC): Describe how the AC will function in
providing oversight of the development, implementation and evaluation of
recruitment strategies; in the recruitment and selection of candidates; in
the evaluation of special curricula and/or links to curricula developed
through a K30 grant (if present); in the monitoring and evaluation of each
candidate’s progress with recommendations for changes in the training plan,
if necessary, or termination of a candidate who is not making adequate
progress; and in monitoring and evaluation of the overall effectiveness of
the Program.
Individual Training Plans: Provide brief summaries of the
individual training plans that the Program will employ or has been able to
achieve (for competing renewal applications) in preparing candidates to
design, implement and participate in patient-oriented research and
collaborate effectively with basic scientists in translational research.
9. Human Subjects: Follow instructions in Form PHS 398 application kit.
10. Vertebrate Animals: Follow instruction in Form PHS 398 application kit.
11. Appendices: Follow instructions in Form PHS 398 application kit.
The completed original application and three legible copies must be sent to
or delivered to:
CENTER FOR SCIENTIFIC RESEARCH
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (For express/courier service)
At the time of submission, two additional copies must also be sent to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062
MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (express/courier service)
Applications will be accepted once every year on June 1. If an application
is received after the deadline, it will be returned to the applicant without
review. If the application submitted in response to this PA is substantially
similar to a grant application already submitted to the NIH for review but
has not yet been reviewed, the applicant will be asked to withdraw either the
pending application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical applications
be reviewed by different review committees. An application, therefore,
cannot be submitted in response to this PA which is essentially identical to
one that has already been reviewed. This does not preclude the submission of
substantial revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the Center
for Scientific Review (CSR) and by the NCI for adherence to the guidelines.
Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened by the NCI in accordance
with the standard NIH peer review procedures. As part of the initial merit
review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under review, will
be discussed, assigned a priority score, and receive a second level review by
the National Cancer Advisory Board.
Review Criteria:
Purpose and Objectives:
- adequacy in representing the required two or more oncology
disciplines among mentors and the trainee population
- clarity of the Program’s objectives
- adequacy in meeting the NCI intent to prepare candidates who can
design and implement all phases of clinical trials research and effectively
lead a translational research project involving clinician and basic
scientists
- track record of the institution in the development of trainees as
productive independent clinician investigators
- adequacy of the commitment of the institution assuring that
candidates will spend a minimum of 75% of a full-time professional effort in
research or research-related career development
Core Requirements:
- quality of the process for evaluating each candidate’s need relative
to all core didactic and core research training requirements
- adequacy of the nature and duration of the core basic and clinical
research requirements
- adequacy of the nature and duration of specialized core didactic
training/curriculum (e.g., biostatistics, clinical trials design, informed
consent etc.)
Research Base/Resources and Facilities/Mentors:
- adequacy of the funded research laboratory and patient-oriented
research base to support a career development Program
- adequacy of the multi-disciplinary interactions present to provide
the proper example of a translational research environment
- adequacy of the available research infrastructure, access to
technologies and methodologies and patient populations to support a career
development Program
- quality of the mentors’ research experience and productivity and
their track records in training basic and patient-oriented researchers.
Program Management:
- adequacy of the Program Leader’s qualifications to lead and
coordinate the Program
- recruitment:
- adequacy of the strategies for attracting and the criteria for selecting
the best clinician candidates
- adequacy of the trainee pool to meet the needs of the Program
- adequacy of the strategies for recruiting minorities
- Advisory Committee:
- appropriateness of the experience of the membership
- adequacy of the AC’s involvement as a quality control in:
i. selecting candidates for participating in the program
ii. establishing appropriate training plans for each candidate based on the
Core Requirements of the Program
iii. monitoring the progress of candidates and making midcourse corrections
to improve the quality of the candidates’ experiences
iv. terminating candidates for evident lack of performance or potential
v. monitoring and evaluating the overall performance of the Program
- the quality and completeness of the individual training plans relative to
the Core Requirements and objective of preparing candidates who can design
and implement all phases of clinical trials research and effectively lead a
a translational research project involving clinician and basic scientists.
5. (For competing renewal applications): quality/success in achieving the
research career development objectives of this Program and meeting the NCI’s
intent
6. Appropriateness of the budget to achieve the objectives of the Program as
proposed.
The initial review group will also examine: the adequacy of plans to
include both genders and minorities in their subgroups as appropriate for the
scientific goals of the research and plans for the recruitment and retention
of subjects; the adequacy of plans for including children as appropriate for
the scientific goals of the research, or justification for exclusion; the
provisions for the protection of human and animal subjects; and the safety of
the research environment.
AWARD CRITERIA
Applications will compete for available funds with all other scored
applications submitted in response to this PA. Following the initial review
for scientific and technical merit, the initial review must be concurred with
by the National Cancer Advisory Board (NCAB). The NCI will notify the
applicant of the NCAB’s action. Final funding decisions are made by the NCI
based on the quality of the proposed Program, as determined by peer review,
the availability of funds, and priorities of the NCI.
NONCOMPETING RENEWAL APPLICATIONS
The procedures for submission of a new or a competing renewal application are
not applicable to applications for a noncompeting renewal of an award.
Noncompeting renewal applications for the K12 grant, as administered by the
NCI, are not subject to the Streamlined Noncompeting Award Process (SNAP) and
require detailed reporting of budgets and progress. The general requirements
for reporting progress annually are outlined in this PA under RESEARCH
OBJECTIVES in the part of section D (Allowable Costs) that refers to Progress
Reports.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic and scientific issues to:
Dr. Lester S. Gorelic
Cancer Training Branch
Office of Centers, Training and Resources
National Cancer Institute
6116 Executive Blvd.
Suite 7011, MSC 8346
Bethesda, MD 20892-8346
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: lg2h@nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Catherine Blount
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-3179
FAX: (301) 496-8601
Email: cb136g@nih.gov
Direct inquiries regarding review issues to:
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062, MSC 8329
Rockville, MD 20852 (express/courier service)
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.398 Cancer Research Manpower. Awards are made under authorization of
sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility)
in which regular or routine education, library, day care, health care or
early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.